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Trials & Filings

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January 21, 2010
Merck’s HIV treatment vicriviroc did not meet the primary efficacy endpoint in two Phase III studies involving patients previously treated with other HIV medicines.   Read More »
January 18, 2010
The FDA has extended the review period for OSI Pharmaceuticals and Genentech’s sNDA for Tarceva (erlotinib) as a first-line maintenance therapy in advanced non-small cell lung cancer (NSCLC) by an additional 90 days.   Read More »
January 13, 2010
Xcellerex, Inc. has initiated a Phase I trial of XRX-001, a prophylactic vaccine against yellow fever, a tropical virus disease that is often fatal.   Read More »
January 6, 2010
Gilead’s Phase II trial of its investigational integrase inhibitor-based, once-daily, fixed-dose “Quad” regimen of GS 9350, elvitegravir and Truvada (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV-1, met its pr   Read More »
January 4, 2010
The FDA has not yet completed its review of the BLA for Prevnar 13, Pfizer’s13-valent pneumococcal conjugate vaccine.   Read More »
December 30, 2009
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) received a Complete Response letter from the FDA for ceftobiprole.   Read More »
December 30, 2009
Valeant Pharmaceuticals’ NDA for the investigational drug retigabine has been accepted for review by the FDA.   Read More »
December 30, 2009
Pfizer has shut down the Phase III trial of figitumumab (CP-751,871)   Read More »
December 28, 2009
Pfizer received a Complete Response letter from the FDA regarding its NDA for Lyrica (pregabalin) capsules CV as a monotherapy treatment for generalized anxiety disorder (GAD).   Read More »
December 28, 2009
Synta Pharmaceuticals Corp. has initiated a Phase II trial of STA-9090, a potent, synthetic, small molecule Hsp90 inhibitor, in patients with advanced gastrointestinal stromal tumors (GIST).   Read More »
December 15, 2009
Darusentan missed its primary endpoints, will likely be canceled.   Read More »
December 8, 2009
Mylan to sell generic Effexor XR in mid-2011   Read More »
December 7, 2009
Roche will discontinue development of Genmab's RG1507, an IFG-1R antibody.   Read More »
December 4, 2009
AZ's Seroquel XR gets adjunctive MDD indication, but also response letter for other sNDAs   Read More »
December 2, 2009
Alexion Pharmaceuticals’s RI facility is near approval as a second source of supply for Soliris.   Read More »
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